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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE

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DEXCOM, INC. DEXCOM G6 SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 5282139
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Event Description
My dexcom g6 sensor failed for the 11th or 12th time in the last year. Prior to 2020 i rarely had issues with dexcom, but nearly every other sensor i wear will now fail. I have asked dexcom about this and they won't give a direct answer of course. I have had to get countless replacement sensors sent to me. They really seem to have an issue with the manufacturing of their sensors lately. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6 SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
DEXCOM, INC.
MDR Report Key11229115
MDR Text Key228956170
Report NumberMW5098995
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/22/2021
12 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10   11   12  
0 Patients were Involved in the Event:
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5282139
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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